Local Anesthesia in Radial Catheterization

Coronary Artery Disease Clinical Trial

— RAOLA  

Official title:

Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03072394
• Other study ID #: HippocratioGH
• Status: Recruiting
• Phase: Phase 4
• First received: February 24, 2017
• Last updated: February 26, 2018
• Start date: January 10, 2015
• Est. completion date: January 10, 2021

Study information

• Verified date: February 2018
• Source: Hippocration General Hospital
• Contact: George Latsios, MD PhD
• Email: glatsios[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.

Description:

A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.

Participants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.

Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.

Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group

Participants will be observed for 4 hours post angiography for development of local complications or side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: January 10, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• referral for elective diagnostic coronary angiography

Exclusion Criteria:

• acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal.

Related Conditions & MeSH terms

• Anesthesia, Local
• Catheter Site Discomfort
• Catheter Site Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Local anesthetic
Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
• local anaesthetic injection
Local skin anesthesia during radial coronary artery catheterization by lidocaine injection

Locations

Country	Name	City	State
Greece	Hippocration Hospital, Athens University Medical School	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale of Pain Perception during sheath insertion	The primary end-point of the study is the perception of radial pain assessed during artery puncture	During artery puncture
Primary	Visual Analog Scale of Pain Perception after sheath removal	The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal	30 minutes after sheath removal
Secondary	Puncture efficiency (number of puncture attempts)	The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.	During radial artery catheterization
Secondary	Radial artery spasm	The occurrence of radial artery spasm in each group during radial artery catheterization	During radial artery catheterization